510(k) K043418 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH
| Applicant | Cook Urological, Inc., Spencer IN, US |
| Decision | Substantially Equivalent, Mar 31, 2005 |
| Received | Dec 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043418
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2007 | Cook Urological, Inc. Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile, REF FUS-095013-DL. Terminated |
FED | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.